THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 is an FDA 510(k)-cleared medical device (K073363) manufactured by Paladin Biomedical Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2008. Regulation: 8.